Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | SYNCHROMED II INFUSION SYSTEM |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P860004 |
Supplement Number | S110 |
Date Received | 07/21/2009 |
Decision Date | 08/20/2009 |
Advisory Committee |
General Hospital |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement AUTOMATION OF THE STEP WHERE DATA IS TRANSFERRED FROM THE CALIBRATION TESTING EQUIPMENT TO FACTORYWORKS, THE MANUFACTURING SOFTWARE THAT CONTROLS THE MANUFACTURING OF THE DEVICE. |
|
|